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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011339
Receipt No. R000013285
Scientific Title Clinical study of laparoscopic rectal resection / amputation for rectal tumor using (da Vinci Surgical System Si) robot assisted surgery
Date of disclosure of the study information 2013/08/01
Last modified on 2018/08/07

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Basic information
Public title Clinical study of laparoscopic rectal resection / amputation for rectal tumor using (da Vinci Surgical System Si) robot assisted surgery
Acronym Clinical study of laparoscopic rectal resection / amputation for rectal tumor using robot assisted surgery
Scientific Title Clinical study of laparoscopic rectal resection / amputation for rectal tumor using (da Vinci Surgical System Si) robot assisted surgery
Scientific Title:Acronym Clinical study of laparoscopic rectal resection / amputation for rectal tumor using robot assisted surgery
Region
Japan

Condition
Condition Rectal tumor
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Clinical study of the safety for laparoscopic rectal resection / amputation for rectal tumor using (da Vinci Surgical System Si) robot assisted surgery.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes 1.Conversion to laparotomy
2.Conversion to conventional laparoscopy
Key secondary outcomes 1.Intra-operative complication
2.Post-operative complication
3.Pathological positive rate of circumferential resection margin
4.Urinary dysfunction
5.Sexual dysfunction
6.3 years rate of local recurrence

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Over 20 years old patient at the time of informed consent.
2.Rectal Tumor, histologically.
3.Performance Status (ECOG) is 0-1.
4.Patients who obtained the document voluntary consent of the patient himself after receiving a sufficient explanation upon participation in this study , on a full understanding.
Key exclusion criteria 1.Patients with pelvic surgery history by laparotomy.
2.Other organs invasive rectal cancer patients.
3.Lateral lymph node metastasis.
4.Patients with a history colon, rectal cancer, excluding mucosal cancer.
5.Patient with investigator has determined to be inappropriate as a subject.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akinobu Taketomi
Organization Hokkaido University Hospital
Division name Gastroenterological Surgery I
Zip code
Address N14W5 Kita-Ku Sapporo
TEL 011-706-5927
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shigenori Homma
Organization Hokkaido University Hospital
Division name Gastroenterological Surgery I
Zip code
Address N14W5 Kita-Ku Sapporo
TEL 011-706-5927
Homepage URL
Email

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Hokkaido University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 北海道大学病院(Hokkaido University Hospital)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 16 Day
Last follow-up date
2018 Year 07 Month 31 Day
Date of closure to data entry
2018 Year 07 Month 31 Day
Date trial data considered complete
2018 Year 07 Month 31 Day
Date analysis concluded
2018 Year 08 Month 31 Day

Other
Other related information 1.Conversion to laparotomy
2.Conversion to conventional laparoscopy
3.Intra-operative complication
4.Post-operative complication
5.Pathological positive rate of circumferential resection margin
6.Urinary dysfunction
7.Sexual dysfunction
8.3 years rate of local recurrence

Management information
Registered date
2013 Year 08 Month 01 Day
Last modified on
2018 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013285

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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